QuickVue TLI H. pylori Test
Basic Information
- Brand Name
- QuickVue TLI H. pylori Test
- Primary DI
- 00857031002561
- Version / Model
- 20343
- Company Name
- TECHLAB, INC.
- Labeler DUNS
- 614218634
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-30
- Public Version
- 2
- Public Version Date
- 2023-08-15
- Public Version Status
- Update
- Public Device Record Key
- d7e90379-e152-4066-9a15-ef1e6d8cec67
- Distribution End Date
- 2023-08-14
Device Description
The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYR | Helicobacter Pylori | Microbiology | 866.3110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50994 | Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857031002561 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181379 | 000 |